This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046study. At the end of M16-046, they have the option to receive Upadacitinib until the investigational drug has been approved by the regulatory authorities in their country and/or applicable local reimbursement approval. There will be a 30 day follow-up visit after the treatment period is completed

Phase 1

• Conditions: Moderate to severe Atopic Dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-001227-12-FI
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

• Subjects should have successfully completed treatment in the M16-046 study, without developing any permanent discontinuation criteria.
• Subject is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the M16-046 study to continue treatment in the long term extension study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 566
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

• Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified